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DOCUMENT NO.: IV11Volume IVORY LABORATORY
MANUALOrientation and
Training FDA Office of Regulatory AffairsVERSION NO.: 1.3
FINAL
EFFECTIVE DATE:
100103
Revised:
021413Office of Regulatory ScienceSection
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What is ora laboratory?
Ora laboratory is a database where information on adverse events related to medical devices is reported and stored.
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Manufacturers, importers, and device user facilities are required to file reports to ora laboratory.
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Reports can be filled out online through the dedicated portal provided by the FDA.
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The purpose of ora laboratory is to track and monitor adverse events related to medical devices for regulatory purposes.
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Information such as the device type, adverse event details, patient information, and reporter contact details must be reported on ora laboratory.
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